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EUROPEAN COMMISSION

Brussels, 21.12.2010

COM(2010) 781 final

2010/0377 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on control of major-accident hazards involving dangerous substances

SEC(2010) 1590 final

SEC(2010) 1591 final

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EXPLANATORY MEMORANDUM

1. CONTEXTOFTHEPROPOSAL

Grounds for and objectives of the proposal

Directive 96/82/EC on the control of major-accident hazards involving dangerous

substances (hereinafter the Seveso II directive) is aimed at preventing major

accidents involving large quantities of dangerous substances (or mixtures thereof) as

listed in its Annex I and to limit the consequences of such accidents for man and the

environment. There is a tiered approach to the level of controls, with the larger the

quantities of substances, the stricter the rules.

The Directive has to be amended due to changes in the EU system of classification of

dangerous substances to which the Directive refers. In the light of this, it was decided

in 2008 to launch a wider review since the basic structure of the Directive and its

main requirements have remained essentially unchanged since its adoption. Althoughthe review has shown that that overall the existing provisions are fit for purpose and

that no major changes are required, a number of areas were identified where limited

amendments would be appropriate in order to clarify and update certain provisions

and to improve implementation and enforceability while maintaining or slightly

increasing the level of protection for health and environment.

The proposal is intended to address these issues.

General context

Industrial accidents involving dangerous substances often have very seriousconsequences. Some well-known major accidents like Seveso, Bhopal,

Schweizerhalle, Enschede, Toulouse and Buncefield have taken many lives and/or

damaged the environment and cost up to billions of euro. In the wake of these

accidents, political awareness has sharpened towards recognising the risks and taking

appropriate precautionary action to protect citizens and communities.

The Seveso II Directive, which covers around 10,000 establishments within the

European Union, has been instrumental in reducing the likelihood and consequences

of chemical accidents. However there is continuing need to ensure that existing high

levels of protection are maintained and if possible further improved.

Existing provisions in the area of the proposal

The current provisions are those established by the Seveso II Directive. The aim is to

revise those provisions.

Consistency with other policies and objectives of the Union

The main reason for the revision of the Seveso II Directive is to align its Annex I to

Regulation (EC) No. 1272/2008 on classification, labelling and packaging of

dangerous substances and mixtures (hereinafter the CLP Regulation), which amends

and repeals Directives 67/548/EEC and 1999/45/EC to which the Seveso II Directive

currently refers. The CLP rules become definitive with effect from 1 June 2015.

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2. CONSULTATION OF INTERESTED PARTIES AND IMPACT

ASSESSMENT

Consultation of interested parties

During the review process over the last two years, stakeholders (individual

companies, industry associations, NGOs, Member State competent authorities) wereconsulted in a number of ways, including web-base questionnaires available for all

stakeholders; consultation of competent authorities in the Member States through the

regular meetings of the committee of competent authorities (CCA) and related

seminars; on the Annex I alignment, via a multi-stakeholder technical working

group, comprising experts from Member States, industry and environmental NGOs

(the technical report from which is available on DG ENV's website); and a

stakeholder consultation meeting held on 9 November 2009 in Brussels, attended by

around 60 representatives from national and European industry and environmental

NGOs as well as individual companies, following which around fifty written

submissions were received.

There was general agreement that no major changes to the Directive are necessary.

There was broad support in principle for further clarifying and updating the

provisions, although views varied on specifics.

Further details can be found in the impact assessment and on DG ENV's website at

http://ec.europa.eu/environment/seveso/review.htm).

Collection and use of expertise

As part of the review process, several studies were carried out by external

contractors. These included two studies assessing the effectiveness of the Directive

and two studies supporting the impact assessment of the economic, social andenvironmental impacts of the various policy options.

The findings from the three-yearly implementation reports from Member States were

also taken into account.

Further details can be found in the impact assessment and on DG ENV's website at

http://ec.europa.eu/environment/seveso/review.htm).

Impact assessment

The main problems covered in the impact assessment related to the alignment of

Annex I to the CLP Regulation and the impact on the scope of the Directive, which

was the key issue. Related to that issue were possible other technical amendments to

Annex I and the procedures for adapting Annex I in the future. Other issues related to

information to the public and information management systems and land-use

planning, where experience of implementation to date indicates that some

opportunities for improvements or new requirements may exist; and other detailed

provisions which could usefully be clarified or updated, in some cases to more

closely reflect existing practices.

The impact assessment assessed a number of policy options with the aim of

identifying a cost-effective package of measures to address these issues. The

assessment has led the Commission to propose a number of amendments, of whichthe main ones are as follows.

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As regards the alignment of Annex I, a simple change of reference or one-to-one

translation from the old classification system to the CLP Regulation is not possible,

mainly because for health hazards the old hazard classification categories 'toxic' and

'very toxic' do not correspond to the new CLP 'Acute Toxicity' 1 to 3, which are

moreover divided into different exposure routes (oral, dermal and inhalation). A

further complication is that as substances are classified or re-classified under the

CLP Regulation over time, this will automatically impact on the scope of the Sevesolegislation. The Commission is proposing the option that, in addition to a very

limited impact on scope shared with other options, maintains a high level of

protection taking into account the most likely and relevant exposure routes in the

event of a major accident. To deal with situations arising over time from the

alignment where substances are included/excluded under the Directive that do/do not

present a major-accident hazard, a package of corrective mechanisms to adapt Annex

I via delegated acts is proposed.

As regards information to the public, etc, it is proposed to improve the level and

quality of information and how this is collected, managed, made available, updated

and shared in an efficient and streamlined way. This will bring the Directive moreinto line with the Aarhus Convention on access to information, public participation in

decision-making and access to justice in environmental matters, update its

procedures to take account of advances in information management systems such as

the internet and the ongoing efforts to improve the efficiency of such systems like the

Shared Environmental Information System (SEIS) initiative and the INSPIRE

Directive (2007/2/EC).

The remaining amendments proposed are relatively minor technical adaptations to

existing provisions.

Taken as a whole, the potential changes considered represent a moderate adaptationof the Directive and would not significantly affect the level of protection or the costs

of the Directive. Overall, the costs of these are low compared with the total costs of

the Directive.

The impact assessment is submitted with this proposal.

3. LEGALELEMENTSOFTHEPROPOSAL

Summary of the proposed action

The aim of the proposal is to revise the Directive to align it to the CLP Regulation

and also to clarify, improve or add certain provisions to ensure better, more

consistent implementation and enforcement of the legislation with the aim of

achieving a high level of protection, while where possible simplifying legislation and

reducing administrative burdens.

Legal basis

The primary objective of the Directive is the protection of the environment. This

proposal is therefore based on Article 192(1) TFEU.320

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Subsidiarity principle

The subsidiarity principle applies insofar as the proposal does not fall under the

exclusive competence of the Union.

The objectives of the proposal cannot be sufficiently achieved by the Member States

since the Seveso II Directive sets goals and objectives for the prevention and controlof major accidents throughout the European Union. This principle is maintained in

the current proposal. In addition, many major accidents can have transboundary

effects. All Member States could be affected by such accidents and therefore need to

take measures in order that the risks to the population and the environment in each

Member State can be reduced. XXXX

Community action will better achieve the objectives of the proposal because of the

need to avoid significantly different levels of protection in the Member States,

particularly in view of possible distortions of competition that could result. The

proposal leaves the detailed means of implementation, compliance and enforcement

to be decided by the appropriate authorities.3

The proposal therefore complies with the subsidiarity principle.

Proportionality principle

The proposal complies with the proportionality principle for the following

reasons.331It follows the goal-setting approach of the Seveso II Directive, leaving

sufficient flexibility to the Member States to determine how to achieve the objectives

laid down. The new provisions do not go beyond what is necessary and the current

proportionate approach, with the level of controls based on the quantities of

dangerous substances present in establishments, is maintained.332

Choice of instrument

The proposed instrument is a directive.34Given the fact that the existing legislation

sets Community objectives while leaving the choice of measures for compliance to

the Member States, the best instrument is a directive. Given the nature and extent of

the changes compared with the current Directive, a revision of that in the form of an

amending Directive or recast would not be appropriate. A new directive is therefore

proposed.

4. BUDGETARYIMPLICATION

The proposal has no implication for the Community budget.

5. ADDITIONAL INFORMATION

Simplification

Some elements of the proposal should help to reduce unnecessary administrative

burden, in particular by encouraging, at Member State level, coordinated inspections,

more integration in information and procedural requirements, and by simplifying and

streamlining implementation reporting requirements through moving towards an

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extended shared information system. Clarifications to existing provisions will also

improve readability and give greater legal certainty.

Repeal of existing legislation

The adoption of the proposal will lead to repeal of the existing Directive.

Correlation table

The Member States are required to communicate to the Commission the text of

national provisions transposing the Directive as well as a correlation table between

those provisions and this Directive.560

European Economic Area

The proposed act concerns an EEA matter and should therefore extend to the

European Economic Area.570

Detailed explanation of the proposal

The following provides information about the specific Articles. Except where

indicated otherwise, the provisions are unchanged in substance from those set out in

Directive 96/82/EC.

Article 1

This Article outlines the aim and objectives of the Directive.

Article 2

Article 2 defines the scope of the Directive, which applies to establishments where

dangerous substances listed in Annex I are present above prescribed thresholds. The

provisions of Article 2 are essentially unchanged from Directive 96/82/EC. However

the order of Parts 1 and 2 of Annex I has been reversed so that Part 1 of Annex I lists

categories of dangerous substances according to their generic hazard classification

(in accordance with the CLP Regulation) and part 2 lists named dangerous

substances or groups of substances that, notwithstanding their generic hazard

classification, warrant specific listing.

The main differences in terms of content of the Annex are as follows.

The main change concerns health hazards. The former category "Very Toxic" has

been aligned to the CLP category "Acute Toxic 1" and "Toxic" to "Acute Toxic 2"

(all exposure routes) and "Acute Toxic 3" (dermal and inhalation routes).

Several more specific CLP categories for physical hazards that did not exist before

replace the more general old categories for oxidizing, explosive, and flammable

hazards. These, together with the environmental hazard categories, represent a

straightforward translation and maintain the current scope in relation to such hazards

as closely as possible. For the new category of flammable aerosols, the thresholds

have been adapted proportionately to those that apply currently based on their

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flammable properties and components; and for reasons of consistency, the group of

pyrophoric substances has been completed by the inclusion of pyrophoric solids.

The new Annex I Part 2 retains the old Part 1 largely unchanged. The only changes

are an updated reference to the CLP Regulation for liquefied flammable gases; the

inclusion of anhydrous ammonia, boron triflouride, and hydrogen sulphide as named

substances, previously covered by their hazard categories, to keep their thresholdsunchanged; the inclusion of heavy fuel oil in the entry for petroleum products;

clarifications to the notes in relation to ammonium nitrate; and an update of the toxic

equivalency factors for dioxins.

Furthermore the exclusions to the Directive previously listed in Article 4 of Directive

96/82/EC are listed here. These are maintained, subject to the following changes:

to remove any possible doubts, the exception to the exclusion for the

exploitation of minerals in mines and quarries or boreholes is amended to

include underground gas storage.

the possibility to exclude substances from being regarded as dangerous

substances for the purposes of the Directive because they do not present a

major-accident hazard (see Article 4).

Among the excluded areas are the offshore exploration and exploitation of minerals,

including hydrocarbons. As announced in its recent communication "Facing the

challenge of the safety of offshore oil and gas operations" in the light of the oil rig

accident in the Gulf of Mexico, the Commission will assess the appropriate way to

strengthen environmental legislation with provisions that may be necessary to

complement existing environmental legislation in relation to pollution control,

inspection and accident prevention and management as regards individual offshoreinstallations, ensuring a high level of protection of the environment in such activities.

Corresponding legislative proposals will include either extending the scope of

existing legislation to offshore oil and gas installations or a stand-alone initiative for

such operations.

Article 3

This Article defines the basic terms used in the Directive. Compared with Directive

96/82/EC, the following changes should be highlighted:

the definitions of "establishment" and "operator" have been clarified, with the

latter brought more into line with the definition in the Industrial Emissions

Directive.

the reference to presence of dangerous substances in Article 2 of Directive

96/82/EC is moved to this Article

definitions are added for the different kinds of establishments falling within the

Directive's scope and "inspections". Definitions are also included for "the

public" and "the public concerned", in line with the EU legislation

implementing the Aarhus Convention.

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the definition of "installation" is clarified to make it clear that underground

installations are included.

Article 4

This new Article provides for correction mechanisms to adapt Annex I as necessary

via delegated acts. This is needed in particular to address unwanted effects from thealignment of Annex I to the CLP Regulation and subsequent adaptations to that

Regulation, which could lead to substances and possibly mixtures being

automatically included in or excluded from the Directive irrespective of whether or

not they present a major accident hazard. The mechanisms would take the form of

EU-wide substance derogations and establishment-specific derogations at Member

State level on the basis of harmonised criteria for substances/mixtures that are caught

but should be excluded, and, as a counterpart, a safeguard provision enabling the

inclusion of non-captured hazards. The criteria for the derogations would be based on

those laid down in Commission Decision 98/433/EC and would be established by

delegated acts by 30 June 2013.

Article 5

This Article repeats the existing requirements of Article 5 of Directive 96/82/EC,

which set out the general obligations on operators.

Article 6

This Article extends the information obligations in relation to notifications set out in

Article 6 of Directive 96/82/EC to include information about neighbouring

establishments, etc, whether or not they are covered by the Directive, needed for the

purposes of Article 8 relating to domino effects. In addition operators will berequired to update their notifications at least every five years. All this will help

competent authorities to manage implementation of the Directive more effectively.

Article 7

Article 7 of Directive 96/82/EC is amended to make it clear that all establishments

must have a major-accident prevention policy (MAPP) proportionate to the hazards.

The scope of the MAPP and its relationship with safety management systems (SMS)

pursuant to Article 9 and Annex III is also clarified, by deleting the reference to the

latter.

New provisions are introduced requiring that the MAPP should be available in

writing and sent to the competent authority and that it should be updated at least

every five years, in line with the proposed frequency for updating notifications under

Article 6.

Article 8

This Article covers so-called domino effects. It maintains the obligation on

competent authorities to identify those establishments that are so close together that

the consequences of a major accident are increased. However the text is clarified to

make it clear that the provisions apply to both upper- and lower-tier establishments

and that the key aim is to ensure that operators exchange information with

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neighbouring establishments, including those that fall outside the scope of the

Directive.

Article 9

This Article maintains the core requirement for upper-tier establishments to prepare a

safety report, previously contained in Article 9 of Directive 96/82/EC. The mainchange is to clarify the relationship with the MAPP and SMS, particularly in respect

of the obligations for lower-tier establishments in the latter regard. The need for a

proportionate approach is also highlighted.

The content of the safety report is detailed in Annex II and remains largely

unchanged (see below). The need for the report to demonstrate that possible major-

accident scenarios have been taken into account is also underlined.

As regards the safety management system (SMS), changes are introduced in Annex

III (see below) to remove the references to the MAPP, which lower-tier

establishments are required to have. At the same time it is underlined that the SMS,in particular for a lower-tier establishment, should a Member State so require, should

be proportionate to the hazards and risks.

The provisions for periodic updating of the safety report are maintained, but with an

express requirement for such updated reports to be communicated without delay to

the competent authorities.

Article 10

This Article requires operators to update their managements systems and procedures

and, in particular, their MAPP and safety report in the event of significant

modifications within their establishment. Minor changes are introduced in line with

changes made to related provisions.

Article 11

Article 11 maintains the requirements relating to emergency planning for upper-tier

establishments previously set out in Article 11 of Directive 96/82/EC, subject to two

minor modifications: to require that public consultation on external emergency plans

is in line with the principles of the relevant provisions of Directive 2003/35/EC

implementing the Aarhus Convention; and to make clearer the separation of

responsibilities between operators and competent authorities in relation to the review,

testing and updating of internal and external emergency plans. In addition, to avoid

significant delays in the completion of plans, which are an essential in terms of

adequate preparedness and response in the event of accidents, a new obligation is for

the competent authority to draw up the external emergency plan within 12 months

after receipt of the necessary information from the operator.

Annex IV details the information to be contained in the plans and carries over the

requirements laid down in the corresponding Annex in Directive 96/82/EC, with

certain amendments (see below).

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Article 12

This Article contains the provisions relating to land-use planning. It is essentially

unchanged from Directive 96/82/EC apart from minor changes such as to clarify that

the aim is to protect the environment as well as human health and that it applies to all

establishments; to provide for measures other than safety distances (which may not

be appropriate) to protect areas of particular natural sensitivity or interest; and toprovide where possible for integration of land-use planning procedures with those

under the Environmental Impact Assessment Directive and similar legislation; and to

provide the possibility for competent authorities to require lower-tier establishments

to provide sufficient risk-related information for the purposes of land-use planning.

These changes will bring the text more into line with its aims and more closely

reflect existing practice.

Article 13

This Article retains the current requirements that information should actively be

made available to persons liable to be affected by a major accident and also keptpermanently available. It leaves open who is responsible for the provision of such

information. The main changes are to extend the information to include basic

information for all establishments (name, address and activities), which is provided

to the Commission under Article 19 of the current Directive, but is not made publicly

available; and for upper-tier establishments, a summary of the major-accident

scenarios and key information from the external emergency plan; and, without

precluding other forms of communication, to have this information kept permanently

available to the public online and provided to a central database at Union level as

provided for in Article 20.

Confidentiality of information is ensured, where necessary and appropriate, byArticle 21.

These changes will make it easier for the public to access relevant information and

be better informed in the vent of an accident. It will also make it easier for competent

authorities to monitor that information is available and kept up to date.

Article 14

This is a new Article that builds on and extends the requirements laid down in Article

13(5) of the current Directive requiring that the public should be able to give its

opinion in certain cases relating to land-use planning, modifications to existingestablishments, external emergency plans, etc. The provisions are largely based on

Directive 2003/35/EC, with the aim to bring the Seveso II Directive more into line

with the corresponding provisions of the Aarhus Convention.

Articles 15 and 16

These two Articles relate to the reporting of major accidents by operators and

competent authorities respectively. The main change is setting a 12 months deadline

for the submission of reports to avoid lengthy delays in the reporting of accidents by

Member States. This, and a change to the quantity threshold set out in Annex VI,

which establishes the criteria for reportable accidents (see below), will aid preventionof future accidents by allowing early reporting and analysis of accidents and near-

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misses involving significant high quantities of dangerous substances so that

information and lessons learned can be shared.

Articles 17,18,19 and 27

These Articles maintain and build upon the existing provisions relating to the role

and responsibilities of competent authorities with the aim of ensuring more effectiveimplementation and enforcement.

Article 17 introduces a requirement for Member States with more than one

competent authority to appoint one to take the lead in coordinating activities. It also

sets out arrangements for cooperation between the competent authorities and the

Commission in activities in support of implementation, using the existing committee

of competent authorities ("the forum") and related technical working groups, such as

development of guidance, exchanges of best practices and consideration of

notifications made pursuant to Article 4.

Article 19 strengthens the existing requirements in relation to inspections. The newprovisions are largely based on Recommendation 2001/331/EEC providing for

minimum criteria for environmental inspections in the Member States and the

Industrial Emissions Directive. The importance of making available sufficient

resources for inspections, and the need to encourage exchange of information, for

example at Union level through the current Mutual Joint Visits Programme for

inspections, is underlined.

Articles 18 and 27 (which is new) set out the measures to be taken in the vent of non-

compliance, including prohibitions of use and other penalties.

Article 20

This Article relates to the availability of information on establishments and major

accidents held by the Commission. The main change is that provisions of the current

Directive are improved and strengthened by extending the current Seveso Plants

Information Retrieval System (SPIRS ) database to include the information to the

public referred to in Article 13 and Annex V and to make that database open to the

public. Access could be either through links to documents directly loaded on to the

system or through links to the websites of Member States and/or operators. This

sharing of information would help to ensure that the public has the necessary

information and allow operators and competent authorities to draw lessons from the

best practices of others.

The database would also be used for the purposes of reporting on implementation by

Member States, which would streamline and simplify the current arrangements.

Article 21

This sets out new rules on confidentiality, which are based on Directive 2003/4/EC

implementing the provisions of the Aarhus Convention relating to public access to

environmental information, which place greater weight on openness and

transparency while providing for non-disclosure of information in duly justified

cases where confidentiality is required such as for security reasons.

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Article 22

This Article is a new provision, bringing the Directive more into line with the Aarhus

Convention by requiring that Member States should ensure that the public concerned,

including interested environmental NGOs, have access to administrative or judicial

review to challenge any acts or omissions that could breach their rights in relation to

access to information pursuant to Articles 13 and 21(1) or consultation andparticipation in decision-making in relation to cases under Article 14.

Articles 23 to 26

Article 23 provides that Annexes I to VII will be adapted to technical progress by

delegated acts (which will also be used to establish criteria for derogation pursuant to

Article 4(4) and the granting of derogations for substances to be listed in Part 3 of

Annex I). The other Articles are standard provisions relating to the exercise of the

delegation of such implementing powers, and the procedures for revocation and

objections.

Articles 28 to 31

These Articles concern transposition by Member States, entry into force of the new

Directive and repeal of Directive 96/82/EC. The date on which Member States shall

apply the Directive, 1 June 2015, is the date on which the CLP Regulation becomes

definitive.

Other Annexes

Annex II contains the items to be considered in the safety report required by Article

9. The content of the different parts of the Annex are largely unchanged compared

with Annex II in Directive 96/82/EC. The main changes are additional requirements

in relation to information about neighbouring establishments, in particular in view ofpossible domino effects, and other external risks and hazards, such as environmental

risks and hazards (point C of Part 1 and point A of Part 4); about lessons learned

from past accidents (point C; Part 4); and about equipment to limit the consequences

of major accidents (point A, part 5).

Annex III relates to the information on management systems and organisational

factors to be covered in the safety report. The main changes are to remove the

references to the MAPP, to clarify that the safety management system should be

proportionate and that internationally recognised systems such as ISO and OSHAS

should be taken into account; and to include references to safety culture. Another

change is a reference to the possible use of safety performance indicators, which can

be an effective tool to improve safety and assist in monitoring, assessment and

enforcement, and to necessary changes to be made following audit and review of

safety management systems.

Annex IV sets out the information to be included in the internal and external

emergency plans required under Article 11. It is identical to Annex IV in Directive

96/82/EC save that the scope of the external emergency plan is extended to make

clearer references to the need to address possible domino effects and off-site

mitigatory actions to address major accident scenarios impacting on the environment.

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Annex V lists the information to be provided to the public in accordance with Article

13. The main changes to the list of requirements are in Part 1, for all establishments,

the inclusion of the following: details of information about major-accident hazards as

set out in the MAPP or safety report (point 5), inspections carried out (point 6) and

where further information can be obtained (point 7); and in Part 2, for upper-tier

establishments, the inclusion of the main types of major-accident scenarios (point 1),

appropriate information from the external emergency plan ( point 5) and whereappropriate transboundary impacts (point 6).

Annex VI is essentially the same as that in the current Directive, listing the criteria

for reporting accidents. The only change is to bring more accidents within the

reporting system by reducing the quantity threshold laid down in section 1.1 to 1% of

the upper-tier threshold.

Annex VII will list the criteria for granting derogations pursuant to article 4. In

accordance with Article 4(4), these criteria shall be adopted by delegated act by 30

June 2013.

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2010/0377 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the control of major-accident hazards involving dangerous substances

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular

Article 192(1) thereof,

Having regard to the proposal from the Commission1,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Council Directive 96/82/EC of 9 December 2006 on the control of major-accident

hazards involving dangerous substances activities4 lays down rules for the prevention

of major accidents which might result from certain industrial activities and with the

limitation of their consequences for human health and the environment.

(2) Major accidents often have serious consequences, as evidenced by accidents like Seveso,

Bhopal, Schweizerhalle, Enschede, Toulouse and Buncefield. Moreover the impact can

extend beyond national borders. This underlines the need to ensure that appropriate

precautionary action is taken to ensure a high level of protection throughout the Union

for citizens, communities and the environment.

(3) Directive 96/82/EC has been instrumental in reducing the likelihood and consequences

of such accidents thereby leading to better protection levels throughout the Union. A

review of the Directive has confirmed that overall the existing provisions are fit for

purpose and that no major changes are required. However, the system established by

Directive 96/82/EC should be adapted to changes to the Union system of classification

1OJ C [], [], p. [].

2 OJ C [], [], p. [].

3 OJ C [], [], p. [].4 OJ L 10, 14.1.1997, p. 13.

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of dangerous substances to which it refers. In addition, a number of other provisions

should be clarified and updated.

(4) It is therefore appropriate to replace Directive 96/82/EC to ensure that that existing

levels of protection are maintained and further improved, by making the provisions

more effective and efficient, and where possible reducing unnecessary administrative

burdens by streamlining or simplification without compromising safety. At the sametime, the new provisions should be clear, coherent and easy to understand to help

improve implementation and enforceability.

(5) The Convention on the Transboundary Effects of Industrial Accidents of the United

Nations Economic Commission for Europe, which was approved on behalf of the

Union by 98/685/EC: Council Decision of 23 March 1998 concerning the conclusion

of the Convention on the Transboundary Effects of Industrial Accidents5, provides for

measures regarding the prevention of, preparedness for and response to industrial

accidents capable of causing transboundary effects as well as for international

cooperation in this field. Directive 96/82/EC implements the Convention within Union

law.

(6) Major accidents can have consequences beyond frontiers, and the ecological and

economic cost of an accident is borne not only by the establishment affected but also

by the Member state concerned. It is therefore necessary to take measures ensuring a

high level of protection throughout the Union.

(7) The provisions of this Directive should apply without prejudice to provisions of Union

law as regards health and safety at work.

(8) Certain industrial activities should be excluded from the scope of this Directive due to

their specific characteristics. These activities are subject to other legislation at Unionor national level providing an equivalent level of safety. The Commission should

however continue to ensure that there are no significant gaps in the existing regulatory

framework, in particular as regards new and emerging risks from other activities, and

take appropriate action where necessary.

(9) Annex I to Directive 96/82/EC lists the dangerous substances falling within its scope,

inter alia by reference to certain provisions of Council Directive 67/548/EEC of 27

June 1967 on the approximation of the laws, regulations and administrative provisions

relating to the classification, packaging and labelling of dangerous substances6 as well

as Directive 1999/45/EC of the European Parliament and of the Council of 31 May

1999 concerning the approximation of the laws, regulations and administrativeprovisions of the Member States relating to the classification, packaging and labelling

of dangerous preparations7. Those Directives have been replaced by Regulation (EC)

No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on

classification, labelling and packaging of substances and mixtures8, which implements

within the Union the Globally Harmonised System of Classification and Labelling of

Chemicals (GHS) that has been adopted at the international level, within the structure

5OJ L 326, 3.12.1998, p. 1.

6 OJ 196, 16.8.1967, p. 1.

7 OJ L 200, 30.7.1999, p. 1.8 OJ L 353, 31.12.2008, p. 1.

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of the United Nations. That Regulation introduces new hazard classes and categories

only partially corresponding to those used under the previous arrangements. Annex I

to Directive 96/82/EC therefore needs to be amended to align it to that Regulation

while maintaining the existing levels of protection of that Directive.

(10) Flexibility is needed in order to be able to amend Annex I to deal with any unwanted

effects from the alignment to Regulation (EC) No 1272/2008 and subsequentadaptations to that Regulation having an impact on the classification of dangerous

substances. On the basis of harmonised criteria to be developed, derogations could be

granted where notwithstanding their hazard classification, substances do not present a

major accident hazard. There should also be a corresponding correction mechanism to

deal with substances that need to be included within the scope of this Directive

because of their major accident hazard potential.

(11) Operators should have a general obligation to take all necessary measures to prevent

major accidents and to mitigate their consequences. Where dangerous substances are

present in establishments above certain quantities the operator should provide the

competent authority with sufficient information to enable it to identify theestablishment, the dangerous substances present and the potential dangers. The

operator should also draw up and send to the competent authority a major-accident

prevention policy setting out the operator's overall approach and measures, including

appropriate safety management systems, for controlling major-accident hazards.

(12) In order to reduce the risk of domino effects, where establishments are sited in such a

way or so close together as to increase the probability and possibility of major

accidents, or aggravate their consequences, operators should cooperate in the exchange

of appropriate information and in informing the public, including neighbouring

establishments that could be affected.

(13) In order to demonstrate that all that is necessary has been done to prevent major

accidents, to prepare contingency plans and response measures, the operator should, in

the case of establishments where dangerous substances are present in significant

quantities, provide the competent authority with information in the form of a safety

report containing details of the establishment, the dangerous substances present, the

installation or storage facilities, possible major accident scenarios and risks analysis,

prevention and intervention measures and the management systems available, in order

to prevent and reduce the risk of major accidents and to enable the necessary steps to

be taken to limit the consequences thereof.

(14) To provide against emergencies, in the case of establishments where dangeroussubstances are present in significant quantities, it is necessary to establish internal and

external emergency plans and to create systems to ensure those plans are tested and

revised as necessary and implemented in the event of a major accident or the

likelihood thereof. The staff of an establishment should be consulted on the internal

emergency plan and the public must be consulted on the external emergency plan.

(15) In order to provide greater protection for residential areas, areas of substantial public

use and the environment, including areas of particular natural interest or sensitivity, it

is necessary for land-use or other relevant policies applied in the Member States to

take account of the need, in the long term, to keep a suitable distance between such

areas and establishments presenting such hazards and, where existing establishments

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are concerned, to take account of additional technical measures so that the risk to

persons is not increased. Sufficient information about the risks and technical advice on

these risks should be taken into account when decisions are taken. Where possible, to

reduce administrative burdens, procedures should be integrated with those under other

Union legislation.

(16) In order to promote access to information on the environment, in accordance with theAarhus Convention on access to information, public participation in decision-making

and access to justice in environmental matters, which was approved on behalf of the

Union by Council Decision 2005/370/EC of 17 February 2005 on the conclusion, on

behalf of the European Community, of the Convention on access to information,

public participation in decision-making and access to justice in environmental

matters9, the level and quality of information to the public should be improved. In

particular, persons likely to be affected by a major accident should be given sufficient

information to inform them of the correct action to be taken in that event. In addition

to providing information in an active way, without the public having to submit a

request, and without precluding other forms of dissemination, it should also be made

available permanently and kept up to date on the internet. At the same time thereshould be appropriate confidentiality safeguards, to address security-related concerns,

among others.

(17) The way information is managed should be in line with the Shared Environmental

Information System (SEIS) initiative introduced by Communication from the

Commission to the Council, the European Parliament, the European Economic and

Social Committee and the Committee of the Regions - Towards a Shared

Environmental Information System (SEIS)10. It should also be in line with Directive

2007/2/EC of the European Parliament and of the Council of 14 March 2007

establishing an Infrastructure for Spatial Information in the European Community

(INSPIRE)11 and its implementing rules, aimed at enabling the sharing ofenvironmental spatial information among public sector organisations and better

facilitating public access to spatial information across the Union. Information should

be held on a publicly available database at Union level, which will also facilitate

monitoring and reporting on implementation.

(18) In line with the Aarhus Convention, effective public participation in decision-making

is necessary to enable the public to express, and the decision-maker to take account of,

opinions and concerns that may be relevant to those decisions, thereby increasing the

accountability and transparency of the decision-making process and contributing to

public awareness of environmental issues and support for the decisions taken.

Members of the public concerned should have access to justice in order to contributeto the protection of the right to live in an environment that is adequate for personal

health and well-being.

(19) In order to ensure that adequate response measures are taken if a major accident

occurs, the operator should immediately inform the competent authorities and

communicate the information necessary for them to assess the impact of that accident.

9 OJ L 124, 17.5.2005, p. 1.

10 COM(2008) 46 final.11 OJ L107, 25.4.2007, p. 1.

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(20) In order to provide for information exchange and to prevent future accidents of a

similar nature, Member States should forward information to the Commission

regarding major accidents occurring in their territory, so that the Commission can

analyze the hazards involved, and operate a system for the distribution of information

concerning, in particular, major accidents and the lessons learned from them. This

information exchange should also cover 'near misses' which Member States regard as

being of particular technical interest for preventing major accidents and limiting theirconsequences.

(21) Member States should determine the competent authorities responsible for ensuring

that operators fulfil their obligations. Where necessary, one authority should take the

lead in coordinating the different authorities or other bodies involved. The competent

authorities and the Commission should cooperate in activities in support of

implementation such as the development of appropriate guidance and exchanges of

best practice. To avoid unnecessary administrative burden, where appropriate

information obligations should be integrated with those under other relevant Union

legislation.

(22) Member States should ensure that competent authorities take the necessary measures

in the event of non-compliance with this Directive. In order to ensure effective

implementation and enforcement, there should be a system of inspections, including a

programme of routine inspections at regular intervals and non-routine inspections.

Where appropriate, inspections should be coordinated with those under other Union

legislation. It is important that sufficient qualified inspectors are available. Competent

authorities should provide appropriate support using tools and mechanisms for

exchanging experience and consolidating knowledge, including at Union level.

(23) The Commission should be empowered to adopt delegated acts in accordance with

Article 290 of the Treaty in respect of the adoption of criteria for derogations andamendments to the Annexes of this Directive.

(24) Member States should lay down rules on penalties applicable to infringements of the

national provisions adopted pursuant to this Directive and ensure that they are

implemented. The penalties should be effective, proportionate and dissuasive.

(25) Since the objectives of the Directive, namely to ensure a high level of protection of

human health and the environment, cannot be sufficiently achieved by Member States

and can, therefore, be better achieved at Union level, the Union may adopt measures in

accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In

accordance with the principle of proportionality, as set out in that Article, thisDirective does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Subject matter

This Directive lays down rules for the prevention of major accidents which involve dangerous

substances, and the limitation of their consequences for human health and the environment,

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with a view to ensuring high levels of protection throughout the Union in a consistent and

effective manner.

Article 2

Scope

1. This Directive shall apply to establishments where dangerous substances are present

in quantities equal to or in excess of the quantities listed in Parts 1 and 2 of Annex I.

2. This Directive shall not apply to any of the following:

(a) military establishments, installations or storage facilities;

(b) hazards created by ionizing radiation;

(c) the transport of dangerous substances and intermediate temporary storage byroad, rail, internal waterways, sea or air, outside the establishments covered by

this Directive, including loading and unloading and transport to and from

another means of transport at docks, wharves or marshalling yards;

(d) the transport of dangerous substances in pipelines, including pumping stations,

outside establishments covered by this Directive;

(e) the exploitation (exploration, extraction and processing) of minerals in mines,

quarries, or by means of boreholes, with the exception of underground gas

storage in natural strata and disused mines and of chemical and thermal

processing operations and storage related to those operations which involvedangerous substances, as defined in Annex I;

(f) the offshore exploration and exploitation of minerals, including hydrocarbons;

(g) waste land-fill sites, including underground waste storage, with the exception

of operational tailings disposal facilities, including tailing ponds or dams,

containing dangerous substances as defined in Annex I, in particular when used

in connection with the chemical and thermal processing of minerals;

(h) substances listed in Part 3 of Annex I.

Article 3

Definitions

For the purposes of this Directive the following definitions shall apply:

1. establishment means the whole location under the control of an operator where

dangerous substances falling within the scope of this Directive are present in one or

more installations, including common or related infrastructures or activities;

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2. 'lower-tier establishment means an establishment where dangerous substances are

present in quantities equal to or in excess of the quantities listed in column 2 of Part

1 of Annex I and column 2 of Part 2 of Annex I, , but less than the quantities listed in

column 3 of Part 1 of Annex I, and column 3 of Part 2 of Annex I;

3. upper-tier establishment means an establishment where dangerous substances are

present in quantities equal to or in excess of the quantities listed in column 3 of Part1 of Annex I, and column 3 of Part 2 of Annex I;

4. 'new establishment' means an establishment that is newly constructed or has yet to

enter into operation;

5. 'existing establishment' means an establishment that fell within the scope of Directive

96/82/EC;

6. 'subsequent establishment' means an establishment that was operating prior to the

entry into force of this Directive but was not previously covered by Directive

96/82/EC and subsequently falls within the scope of this Directive;

7. installation means a technical unit within an establishment in which dangerous

substances are produced, used, handled or stored, including underground, and

includes all the equipment, structures, pipework, machinery, tools, private railway

sidings, docks, unloading quays serving the installation, jetties, warehouses or

similar structures, floating or otherwise, necessary for the operation of the

installation;

8. operator means any natural or legal person who operates or controls an

establishment or installation or, where this is provided for by national legislation, to

whom decisive economic power over the technical functioning of the establishmentor installation has been delegated;

9. dangerous substance means a substance or mixture listed in Part 1 or Part 2 of

Annex 1 and present as a raw material, product, by-product, residue or intermediate,

including those substances which it is reasonable to suppose may be generated in the

event of accident;

10. 'mixture' means a mixture or solution composed of two or more substances;

11. presence of dangerous substances means the actual or anticipated presence of

dangerous substances in the establishment, or the presence of dangerous substances

which it is believed may be generated during loss of control of an industrial chemical

process, in quantities equal to or in excess of the thresholds set out in Parts 1 and 2 of

Annex I.

12. major accident means an occurrence such as a major emission, fire, or explosion

resulting from uncontrolled developments in the course of the operation of any

establishment covered by this Directive, and leading to serious danger to human

health, property or the environment, immediate or delayed, inside or outside the

establishment, and involving one or more dangerous substances;

13. hazard means the intrinsic property of a dangerous substance or physical situation,

with a potential for creating damage to human health or the environment;

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14. risk means the likelihood of a specific effect occurring within a specified period or

in specified circumstances;

15. storage means the presence of a quantity of dangerous substances for the purposes

of warehousing, depositing in safe custody or keeping in stock;

16.

'the public' means one or more natural or legal persons and, in accordance withnational law or practice, their associations, organisations or groups;

17. 'the public concerned' means the public affected or likely to be affected, or having an

interest in the taking a decision on any of the matters covered by Article 14(1),

including non-governmental organizations promoting environmental protection and

meeting any applicable requirements under national law ;

18. 'inspection' means all actions, including site visits, checks of internal measures,

systems and reports and follow-up documents, and any necessary follow-up,

undertaken by or on behalf of the competent authority to check and promote

compliance of establishments with the requirements of this Directive.

Article 4

Derogation and safeguard clauses

1. Where it is demonstrated, on the basis of the criteria referred to in paragraph 4 of this

Article, that particular substances covered by Parts 1 or 2 of Annex I are incapable of

creating a major accident hazard, in particular due to their physical form, properties,

classification, concentration or generic packaging, the Commission may list those

substances in Part 3 of Annex I by delegated acts in accordance with Article 24.

2. Where a Member State considers that a dangerous substance listed in Parts 1 or 2 of

Annex I does not present a major accident hazard and may qualify for inclusion in

Part 3 of Annex I in accordance with paragraph 1 of this Article, it shall notify the

Commission.

The Commission shall inform the forum referred to in Article 17(2) of such

notifications.

3. Where it is demonstrated to the satisfaction of a competent authority, on the basis of

the criteria referred to in paragraph 4 of this Article, that particular substancespresent at an individual establishment or any part thereof and listed in Parts 1 or 2 of

Annex I are incapable of creating a major accident hazard, due to the specific

conditions pertaining in the establishment such as the nature of the packaging and

containment of the substance or the location and quantities involved, the Member

State of the competent authority may decide not to apply the requirements set out in

Articles 7 to 19 of this Directive to the establishment concerned.

In the cases referred to in the first subparagraph the Member State concerned shall

provide to the Commission a list of the establishments concerned, including the

inventory of dangerous substances concerned. The Member State concerned shall

give reasons for the exclusion.

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The Commission shall forward annually the lists referred to in the second

subparagraph of this paragraph to the forum referred to in Article 17(2) for

information.

4. By 30 June 2013, the Commission shall adopt delegated acts in accordance with

Article 24, to establish criteria to be used for the purposes of paragraphs 1 and 3 of

this Article respectively, and to amend Annex VII accordingly.

5. Where a Member State considers that a dangerous substance not listed in Parts 1 or 2

of Annex I, presents a major-accident hazard, it may take appropriate measures and

shall notify the Commission.

The Commission shall inform the forum referred to in Article 17(2) of notifications

made pursuant to the first subparagraph of this paragraph.

Where appropriate, the Commission may list the substances referred to in the first

subparagraph of this paragraph in Part 1 or Part 2 of Annex I by delegated acts in

accordance with Article 24.

Article 5

General obligations of the operator

1. Member States shall ensure that the operator is obliged to take all measures

necessary to prevent major accidents and to limit their consequences for human

health and the environment.

2. Member States shall ensure that the operator is required to prove to the competentauthority referred to in Article 17 (hereinafter competent authority), at any time, in

particular for the purposes of the inspections and controls referred to in Article 19,

that the operator has taken all the measures necessary as specified in this Directive.

Article 6

Notification

1.

Member States shall require the operator to send the competent authority anotification containing the following details:

(a) the name or trade name of the operator and the full address of the establishment

concerned;

(b) the registered place of business of the operator, with the full address;

(c) the name or position of the person in charge of the establishment, if different

from point (a);

(d) information sufficient to identify the dangerous substances or category of

substances involved;

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(e) the quantity and physical form of the dangerous substance or substances

involved;

(f) the activity or proposed activity of the installation or storage facility;

(g) the immediate environment of the establishment, elements liable to cause a

major accident or to aggravate the consequences thereof, including details ofneighbouring establishments, whether or not those are covered by this

Directive, as well as other sites, areas and developments that could increase the

risk or consequences of a major accident and of domino effects.

2. The notification shall be sent to the competent authority within the following time-

limits:

(a) for new establishments, a reasonable period of time prior to the start of

construction or operation,

(b) for existing establishments, one year from the date laid down in the second

subparagraph of Article 28(1),

(c) for subsequent establishments, one year from the date on which this Directive

applies to the establishment concerned.

3. Paragraphs 1 and 2 of this Article shall not apply to existing establishments if the

operator has already sent a notification to the competent authority under the

requirements of national law at the date laid down in the second subparagraph of

Article 28(1), and the information contained therein complies with paragraph 1 of

this Article and remains unchanged.

4. The operator shall immediately inform the competent authority of the followingevents:

(a) any significant increase in the quantity or significant change in the nature or

physical form of the dangerous substance present, as indicated in the

notification provided by the operator pursuant to paragraph 1, or any change in

the processes employing it,

(b) modification of an establishment or an installation which could have

significant repercussions on major accident hazards,

(c) permanent closure of the installation.

5. Without prejudice to paragraph 4, the operator shall periodically review and where

necessary update the notification, at least every five years. The operator shall send

the updated notification to the competent authority without delay.

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Article 7

Major-accident prevention policy

1. Member States shall require the operator to draw up a document setting out the

major-accident prevention policy (hereinafter: "MAPP") and to ensure that it is

properly implemented. The MAPP shall be established in writing. It shall be

designed to guarantee a high level of protection for human health and the

environment. It shall be proportionate to the major-accident hazards. It shall include

the operator's overall aims and principles of action, the role and responsibility of

management and shall address safety culture with respect to the control of major-

accident hazards.

2. The MAPP shall be sent to the competent authority within the following time-limits:

(a) for new establishments, a reasonable period of time prior to the start of

construction or operation;

(b) for existing establishments, one year from the date laid down in the second

subparagraph of Article 28(1)

(c) for subsequent establishments, one year from the date on which this Directive

applies to the establishment concerned.

3. Paragraphs 1 and 2 of this Article shall not apply to existing establishments if the

operator has already established the MAPP in writing and sent it to the competent

authority under the requirements of national law at the date laid down in the second

subparagraph of Article 28(1), and the information contained therein complies with

paragraph 1 and remains unchanged.

4. The operator shall periodically review and where necessary update the MAPP, at

least every five years. The updated MAPP shall be sent to the competent authority

without delay.

Article 8

Domino effect

1. Member States shall ensure that the competent authority, using the information

received from the operators in compliance with Articles 6 and 9 or through

inspections pursuant to Article 19, identifies all lower-tier and upper-tier

establishments or groups of establishments where the likelihood and the possibility

or consequences of a major accident may be increased because of the location and

the proximity of such establishments, and their inventories of dangerous substances.

2. Member States shall ensure that operators of the establishments identified in

accordance with paragraph 1:

a) exchange suitable information in an appropriate manner to enable thoseestablishments to take account of the nature and extent of the overall hazard of

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a major accident in their MAPP, safety management systems, safety reports

and internal emergency plans;

b) cooperate in informing the public and neighbouring establishments that fall

outside the scope of this Directive, and in supplying information to the

authority responsible for the preparation of external emergency plans.

Article 9

Safety report

1. Member States shall require the operator of an upper-tier establishment to produce a

safety report for the purposes of:

(a) demonstrating that a MAPP and a safety management system for implementing

it have been put into effect in accordance with the information set out in Annex

III;

(b) demonstrating that major-accident hazards and possible major-accident

scenarios have been identified and that the necessary measures have been taken

to prevent such accidents and to limit their consequences for human health and

the environment;

(c) demonstrating that adequate safety and reliability have been taken into account

in the design, construction, operation and maintenance of any installation,

storage facility, equipment and infrastructure connected with its operation

which are linked to major-accident hazards inside the establishment;

(d) demonstrating that internal emergency plans have been drawn up and

supplying information to enable the external emergency plan to be drawn up;

(e) providing sufficient information to the competent authorities to enable

decisions to be made regarding the siting of new activities or developments

around existing establishments.

2. The safety report shall contain at least the data and information

listed in Annex II. It shall name the relevant organisations involved in

the drawing up of the report. It shall also contain an updated inventory

of the dangerous substances present in the establishment.

3. The safety report shall be sent to the competent authority within the following time-

limits:

(a) for new establishments, a reasonable period of time prior to the start of

construction or operation;

(b) for existing establishments, one year from the date laid down in the second

subparagraph of Article 28(1)

(c) for subsequent establishments, two years from the date on which this Directiveapplies to the establishment concerned..

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4. Paragraphs 1, 2 and 3 of this Article shall not apply to existing establishments if the

operator has already sent the safety report to the competent authority under the

requirements of national law at the date laid down in Article 28(1), and the information

contained therein complies with paragraphs 1 and 2 of this Article and remains

unchanged.

5. The operator shall periodically review and where necessary update the safety reportat least every five years.

The operator shall also review and where necessary update the safety report at any

other time at the initiative of the operator or the request of the competent authority,

where justified by new facts or by new technological knowledge about safety

matters, including knowledge arising from analysis of accidents or, as far as possible,

'near misses', and by developments in knowledge concerning the assessment of

hazards.

The updated safety report shall be sent to the competent authority without delay.

6. Before the operator commences construction or operation, or in the cases referred to in

points (b) and (c) of paragraph 3 and in paragraph 5, the competent authority shall within

a reasonable period of receipt of the report:

(a) communicate the conclusions of its examination of the safety report to the

operator,

(b) prohibit the bringing into use, or the continued use, of the establishment

concerned, in accordance with Article 18.

7. Member States may require lower-tier establishments to implement the MAPP by

means of a safety management system proportionate to the major-accident hazards,

and to the complexity of the organization or activities of the establishment.

Article 10

Modification of an installation, an establishment or a storage facility

In the event of the modification of an installation, establishment, storage facility, or process or

of the nature or quantity of dangerous substances which could have significant repercussions

on major-accident hazards, the Member States shall ensure that the operator:

(a) reviews and where necessary revises the MAPP;

(b) reviews, and where necessary revises, the safety report and the safety management

systems and procedures referred to in Article 9 and informs the competent authority

of the details of that revision in advance of that modification.

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Article 11

Emergency plans

1. Member States shall ensure that, for all upper-tier establishments:

(a) the operator draws up an internal emergency plan for the measures to be taken

inside the establishment;

(b) the operator supplies the necessary information to the competent authorities, to

enable the latter to draw up external emergency plans;

(c) the authorities designated for that purpose by the Member State draw up an

external emergency plan for the measures to be taken outside the establishment

within one year following receipt of the information from the operator pursuant

to point (b).

2. Operators shall comply with the obligations set out in points (a) and (b) of paragraph1within the following time limits:

(a) for new establishments, prior to the start of operation;

(b) for existing establishments, one year from the date laid down in the second

subparagraph of Article 28(1) unless the internal emergency plan drawn up

under the requirements of national law at that date, and the information

contained therein, complies with this Article and remains unchanged.

(c) for subsequent establishments, one year from the date on which this Directive

applies to the establishment concerned.

3. The emergency plans shall be established with the following objectives:

(a) containing and controlling incidents so as to minimize the effects, and to limit

damage to human health, the environment and property,

(b) implementing the measures necessary to protect human health and the envir-

onment from the effects of major accidents,

(c) communicating the necessary information to the public and to the services or

authorities concerned in the area,

(d) providing for the restoration and clean-up of the environment following a

major accident.

Emergency plans shall contain the information set out in Annex IV.

4. Without prejudice to the obligations of the competent authorities, Member States

shall ensure that the internal emergency plans provided for in this Directive are

drawn up in consultation with the personnel working inside the establishment,

including long-term relevant subcontracted personnel, and that the public is

consulted on external emergency plans when they are established or updated.

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Member States shall ensure that consultation with the public is in accordance with

Article 14.

5. Member States shall ensure that internal and external emergency plans are reviewed,

tested, and where necessary revised and updated by the operators and designated

authorities respectively at suitable intervals of no longer than three years. The review

shall take into account changes occurring in the establishments concerned or withinthe emergency services concerned, new technical knowledge, and knowledge

concerning the response to major accidents.

With regard to external emergency plans, Member States shall take into account the

need to facilitate enhanced cooperation in civil protection assistance in major

emergencies.

6. Member States shall ensure that emergency plans are put into effect without delay by

the operator and, if necessary, by the competent authority designated for this purpose

when a major accident occurs, or when an uncontrolled event occurs which by its

naturecould reasonably be expected to lead to a major accident.

7. The competent authority may decide, in view of the information contained in the

safety report, that the requirement to produce an external emergency plan under

paragraph 1 shall not apply.

The competent authority shall give reasons for its decision.

Article 12

Land-use planning

1. Member States shall ensure that the objectives of preventing major accidents and

limiting the consequences of such accidents for human health and the environment

are taken into account in their land-use policies or other relevant policies. They shall

pursue those objectives through controls on:

(a) the siting of new establishments;

(b) modifications to existing establishments covered by Article 10;

(c) new developments including transport links, locations frequented by the publicand residential areas in the vicinity of existing establishments, where the siting

or developments may increase the risk or consequences of a major accident.

2. Member States shall ensure that their land-use or other relevant policies and the

procedures for implementing those policies take account of the need, in the long

term:

(a) to maintain appropriate safety distances between establishments covered by

this Directive and residential areas, buildings and areas of public use, major

transport routes as far as possible, and recreational areas;

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(b) to protect areas of particular natural sensitivity or interest in the vicinity of

establishments covered by this Directive, through appropriate safety distances

or other appropriate measures where necessary;

(c) in the case of existing establishments, to take additional technical measures in

accordance with Article 5 so as not to increase the risks to human health and

the environment.

3. Member States shall ensure that all competent authorities and planning authorities

responsible for decisions in this area set up appropriate consultation procedures to

facilitate implementation of the policies established under paragraph 1. The

procedures shall be designed to ensure that operators provide sufficient information

on the risks arising from the establishment and that technical advice on those risks is

available, either on a case-by-case or on a generic basis, when decisions are taken.

Member States shall ensure that operators of lower-tier establishments provide, at the

request of the competent authority, sufficient information on the risks arising from

the establishment necessary for land-use planning purposes.

4. The requirements of paragraphs 1, 2 and 3 shall apply without prejudice to the

provisions of Council Directive 85/337/EEC12 and Directive 2001/42/EC of the

European Parliament and of the Council13. Member States shall where possible and

appropriate provide for coordinated or joint procedures in order to fulfil the

requirements of this Article and the requirements of those Directives, inter alia, to

avoid duplication of assessment or consultations.

Article 13

Information to the public

1. Member States shall ensure that the information referred to in Annex V is

permanently available to the public, including in an electronic format. The

information shall be reviewed and where necessary updated at least once a year.

2. For upper-tier establishments, Member States shall also ensure that:

a) all persons liable to be affected by a major accident receive regularly and in the

most appropriate form, without their having to request it, information on safety

measures and requisite behaviour in the event of an accident;

b) the safety report is made available to the public upon request subject to Article

21(3); where Article 21(3) applies, an amended report in the form of a non-

technical summary, which shall include at least general information on major-

accident hazards, potential effects and the requisite behaviour in the event of an

accident, shall be made available;

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c) the inventory of dangerous substances is made available to the public

concerned upon request subject to Article 21(3).

The information to be supplied under point (a) of this paragraph shall include at least

the information referred to in Annex V. That information shall likewise be supplied

to all establishments serving the public, including schools and hospitals, and to all

neighbouring establishments in the case of establishments covered by Article 8.Member States shall ensure that the information is supplied and that it is periodically

reviewed and updated at least every five years.

3. Requests for access to the information referred to in paragraph 2(a), (b) and (c) shall be

handled in accordance with Articles 3 and 5 of Directive 2003/4/EC of the European

Parliament and of the Council14.

4. Member States shall, with respect to the possibility of a major accident with

transboundary effects originating in an establishment under Article 9, provide

sufficient information to the potentially affected Member States so that all relevant

provisions contained in Articles 11, 12 and this Article can be applied, whereapplicable, by the potentially affected Member States.

5. Where the Member State concerned has decided that an establishment close to the

territory of another Member State is incapable of creating a major-accident hazard

beyond its boundary for the purposes of Article 11(6) and is not therefore required to

produce an external emergency plan under Article 11(1), it shall so inform the other

Member State.

6. This Article shall apply subject to the provisions of Article 21.

Article 14

Public consultation and participation in decision-making

1. Member States shall ensure that the public is able to give its opinion on the following

matters:

(a) planning for new establishments pursuant to Article 12;

(b) modifications to existing establishments under Article 10, where such

modifications are subject to obligations provided for in this Directive as toplanning;

(c) new developments around existing establishments where the siting or

developments may increase the risk or consequences of a major accident

pursuant to Article 12;

(d) external emergency plans pursuant to Article 11(1)(c)

14 OJ L 41, 14.2.2003, p. 26.

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2. The public shall be informed by public notices or other appropriate means, including

electronic media where available, of the following matters early in the procedure for

the taking of a decision or, at the latest, as soon as the information can reasonably be

provided:

(a) the matters set out in paragraph 1;

(b) where applicable, the fact that a decision is subject to a national or

transboundary environmental impact assessment or to consultations between

Member States in accordance with Article 13(4);

(c) details of the competent authority responsible for taking the decision, that from

which relevant information can be obtained, that to which comments or

questions can be submitted, and details of the time schedule for transmitting

comments or questions;

(d) the nature of possible decisions or, where there is one, the draft decision;

(e) an indication of the times and places where, or means by which, the relevant

information will be made available;

(g) details of the arrangements for public participation and consultation made

pursuant to paragraph 5.

3. Member States shall ensure that, within appropriate time-frames, the following is

made available to the public concerned:

(a) in accordance with national legislation, the main reports and advice issued to

the competent authority or authorities at the time when the public concerned

was informed in accordance with paragraph 2;

(b) in accordance with the provisions of Directive 2003/4/EC information other

than that referred to in paragraph 2 which is relevant for the decision in

question and which only becomes available after the public concerned was

informed in accordance with paragraph 2.

4. Member States shall ensure that the public concerned is entitled to express comments and

opinions to the competent authority before a decision is taken and that the results of the

consultations held pursuant to paragraph 1 are duly taken into account in the taking of a

decision.

5. The detailed arrangements for informing the public and consulting the public concerned

shall be determined by the Member States.

Reasonable time-frames for the different phases shall be provided, allowing

sufficient time for informing the public and for the public concerned to prepare and

participate effectively in environmental decision-making subject to the provisions of

this Article.

6. Member States shall ensure that when the relevant decisions are taken, the competent

authority shall make available to the public:

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(a) the content of the decision and the reasons on which it is based, including any

subsequent updates;

(b) the results of the consultations held before the decision was taken and an

explanation of how they were taken into account in that decision.

Article 15

Information to be supplied by the operator following a major accident

1. Member States shall ensure that, as soon as practicable following a major accident,

the operator shall be required, using the most appropriate means:

(a) to inform the competent authorities;

(b) to provide them with the following information as soon as it becomes

available:

(i) the circumstances of the accident;

(ii) the dangerous substances involved;

(iii) the data available for assessing the effects of the accident on human

health and the environment;

(iv) the emergency measures taken;

(c) to inform them of the steps envisaged:

(i) to alleviate the medium- and long-term effects of the accident;

(ii) to prevent any recurrence of such an accident;

(d) to update the information provided if further investigation reveals additional

facts which alter that information or the conclusions drawn.

2. Member States shall require the competent authority:

(a) to ensure that any urgent, medium- and long-term measures which may prove

necessary are taken;

(b) to collect, by inspection, investigation or other appropriate means, the

information necessary for a full analysis of the technical, organizational and

managerial aspects of the major accident;

(c) to take appropriate action to ensure that the operator takes any necessary

remedial measures; and

(d) to make recommendations on future preventive measures.

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Article 16

Information to be supplied by the Member States following a major accident

1. For the purpose of prevention and mitigation of major accidents, Member States shall

inform the Commission as soon as practicable of major accidents meeting the criteria

of Annex VI which have occurred within their territory. They shall provide it with

the following details:

(a) the Member State, the name and address of the authority responsible for the

report;

(b) the date, time and place of the major accident, including the full name of the

operator and the address of the establishment involved;

(c) a brief description of the circumstances of the accident, including the

dangerous substances involved, and the immediate effects on human health and

the environment;

(d) a brief description of the emergency measures taken and of the immediate

precautions necessary to prevent recurrence.

2. Member States shall inform the Commission of the result of their analysis and

recommendations, as soon as practicable and at the latest within one year of the date

of the accident, using the database referred to in Article 20(5).

Reporting of the information referred to in the first subparagraph by Member States

may be delayed only to allow for the completion of legal proceedings where such

reporting may affect those proceedings.

3. The Commission shall establish a report form in close cooperation with the Member

States. Member States shall use that report form when providing the information

referred to in paragraph 1 and paragraph 2.

4. Member States shall inform the Commission of the name and address of any body

which might have relevant information on major accidents and which is able to

advise the competent authorities of other Member States which